Z-2829-2018Class II

Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive

Name: Z-2829-2018 Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive
Creator: Withings Sas
Published: 2018-06-11
License: https://open.fda.gov/license/

Withings SAS / initiated 2018-06-11 / Completed

FDA source

Withings Sas began a recall of Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive on 2018-06-11. FDA classified it as Class II and gives the reason as "Device could not meet the requirements for systolic pressure". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-2829-2018
Classification: Class II
Status: Completed
Initiated: 2018-06-11
Posted: 2018-08-16
Recalling firm: Withings SAS
Product: Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive
Product code: DXN System, Measurement, Blood-Pressure, Non-Invasive
Reason for recall: Device could not meet the requirements for systolic pressure
FDA root cause: Component change control
Action: Beginning on June 11, 2018, All end-users who have installed a device will be notified of the recall both by a CRM email and a warning content showing in the companion mobile application. End-users who start using the device after the recall initiation date will be notified upon installation by email and app content as well. Retailers, distributors and partners will also be notified. Upon notification of the recall, the users will be presented with the alternative of either choosing to keep their device or send it back and get a refund. If they chose to get a refund, end-users will be asked to fill-out a form to receive a return waybill and get a refund in exchange of their product. Customers having purchased their device from a retailer will be eligible for a refund as well.
Quantity in commerce: Total 44,000 units (15,139 US/ 28,861 OUS)
Distribution: US Nationwide Distribution
Product codes and lots: 7024260310

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2829-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2829-2018	Class II	Completed	Voluntary: Firm initiated	2018-08-22	2018-08-16

Product code DXN

K133125Class IIWithings Blood Presure MonitorWithings / cleared 2014-03-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)